{"entity":{"id":"apalutamide","kind":"drug","name":"Apalutamide","aka":[],"tldr":"An AR blocker approved for prostate cancer that has spread and for high-risk disease before it shows on scans.","summary":"Apalutamide is a second-generation androgen receptor antagonist with lower CNS penetration than enzalutamide, intended to reduce seizures and cognitive effects while blocking the receptor as completely. It is given with androgen deprivation for non-metastatic castration-resistant prostate cancer and for metastatic hormone-sensitive disease. SPARTAN (nmCRPC) showed an overall survival benefit and TITAN (mHSPC) reduced deaths by about a third (OS HR 0.65), supporting the 2018 and 2019 approvals. Rash and hypothyroidism are its distinctive side effects and distinguish it from enzalutamide and darolutamide. There is no head-to-head trial among the three AR antagonists, so choice rests on side-effect profile and trial populations. In plain terms, it is an AR-blocking pill used both for cancer that has spread and for high-risk disease that has not yet shown on scans.","status":"approved","asOf":"2026-09-06","wikipedia":"https://en.wikipedia.org/wiki/Apalutamide","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Apalutamide"},{"label":"NICE TA741: apalutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta741"},{"label":"NICE TA740: apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta740"}],"tags":[],"related":[],"cancers":["prostate","prostate-nmcrpc","prostate-mhspc","salivary-duct-carcinoma"],"sections":[],"technologies":["androgen-deprivation"],"targets":["androgen-receptor"],"drugs":[],"companies":["johnson-johnson"],"institutions":[],"pathways":["ar-signaling"],"terms":["mcrpc-mhspc","prostate-uk-drug-approvals"],"trials":["nct05884398","nct07611110","nct02489318","nct05422911","nct05367440","nct07745361","nct04557059","nct02257736","nct03767244","nct02531516","nct01946204","nct04325828"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["NICE TA741 recommends apalutamide with androgen deprivation for hormone-sensitive metastatic prostate cancer only if docetaxel is not suitable: the committee found it not cost effective against docetaxel but within the acceptable range against androgen deprivation alone. NICE TA740 recommends apalutamide with androgen deprivation for high-risk hormone-relapsed non-metastatic prostate cancer, high risk being a PSA that has doubled in 10 months or less on continuous androgen deprivation."],"brand":"Erleada","modality":"Small-molecule AR antagonist","mechanism":"Second-generation AR antagonist with lower CNS penetration than enzalutamide.","approvals":[{"region":"US","year":2018,"indication":"Non-metastatic CRPC (SPARTAN)"},{"region":"US","year":2019,"indication":"mHSPC (TITAN)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/apalutamide/","neighbours":{"cancer":[{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate-nmcrpc","kind":"cancer","name":"Non-metastatic castration-resistant prostate cancer","route":"/cancers/prostate-nmcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"},{"id":"salivary-duct-carcinoma","kind":"cancer","name":"Salivary duct carcinoma","route":"/cancers/salivary-duct-carcinoma/"}],"technology":[{"id":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"}],"target":[{"id":"androgen-receptor","kind":"target","name":"Androgen receptor","route":"/targets/androgen-receptor/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"pathway":[{"id":"ar-signaling","kind":"pathway","name":"Androgen receptor signalling","route":"/pathways/ar-signaling/"},{"id":"prostate-cancer-signalling","kind":"pathway","name":"Prostate cancer (KEGG map)","route":"/pathways/prostate-cancer-signalling/"}],"term":[{"id":"disease-volume-chaarted","kind":"term","name":"Disease volume (CHAARTED high-volume versus low-volume) and LATITUDE risk","route":"/terms/disease-volume-chaarted/"},{"id":"mcrpc-mhspc","kind":"term","name":"mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer)","route":"/terms/mcrpc-mhspc/"},{"id":"prostate-uk-drug-approvals","kind":"term","name":"Prostate cancer drugs in England: what NICE recommends, and what it refuses","route":"/terms/prostate-uk-drug-approvals/"},{"id":"psa-kinetics","kind":"term","name":"PSA kinetics: PSA doubling time and PSA density","route":"/terms/psa-kinetics/"}],"trial":[{"id":"nct04557059","kind":"trial","name":"A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer","route":"/trials/nct04557059/"},{"id":"nct05884398","kind":"trial","name":"A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC","route":"/trials/nct05884398/"},{"id":"nct01946204","kind":"trial","name":"A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer","route":"/trials/nct01946204/"},{"id":"nct02489318","kind":"trial","name":"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC","route":"/trials/nct02489318/"},{"id":"nct04325828","kind":"trial","name":"A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma","route":"/trials/nct04325828/"},{"id":"nct03767244","kind":"trial","name":"A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy","route":"/trials/nct03767244/"},{"id":"nct05422911","kind":"trial","name":"Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.","route":"/trials/nct05422911/"},{"id":"nct02257736","kind":"trial","name":"An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)","route":"/trials/nct02257736/"},{"id":"nct02531516","kind":"trial","name":"An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS","route":"/trials/nct02531516/"},{"id":"nct07611110","kind":"trial","name":"AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","route":"/trials/nct07611110/"},{"id":"nct03777982","kind":"trial","name":"Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT","route":"/trials/nct03777982/"},{"id":"nct05367440","kind":"trial","name":"Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer","route":"/trials/nct05367440/"},{"id":"nct07745361","kind":"trial","name":"Study of Oral MRT-2359 With Apalutamide in Prostate Cancer","route":"/trials/nct07745361/"},{"id":"nct04423211","kind":"trial","name":"Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging","route":"/trials/nct04423211/"},{"id":"nct04513717","kind":"trial","name":"Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial","route":"/trials/nct04513717/"}],"person":[{"id":"charles-sawyers","kind":"person","name":"Charles L. Sawyers","route":"/people/charles-sawyers/"}],"paper":[{"id":"paper-spartan-nejm-2018","kind":"paper","name":"SPARTAN: apalutamide for non-metastatic castration-resistant prostate cancer","route":"/key-papers/paper-spartan-nejm-2018/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}